Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

InZone IST Detachment System; IZDS Connecting Cable

K-Number: K251832 · 2025-10-17

ApplicantStryker Neurovascular
Decision Date2025-10-17
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

InZone IST Detachment System; IZDS Connecting Cable is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K251832. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InZone IST Detachment System; IZDS Connecting Cable?

InZone IST Detachment System; IZDS Connecting Cable is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Stryker Neurovascular. The 510(k) number is K251832.

When did InZone IST Detachment System; IZDS Connecting Cable receive FDA 510(k) clearance?

InZone IST Detachment System; IZDS Connecting Cable received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251832.

Who is the listed applicant for InZone IST Detachment System; IZDS Connecting Cable?

The FDA 510(k) record lists Stryker Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InZone IST Detachment System; IZDS Connecting Cable?

The FDA product code for InZone IST Detachment System; IZDS Connecting Cable is HCG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04195568Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter SystemACTIVE_NOT_RECRUITING

Other records listing Stryker Neurovascular as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261889Trevo Trak 21 MicrocatheterPMA P170024Intracranial aneurysm flow diverterK253032AXS Lift Intracranial Base CatheterK252694Target Detachable CoilPMA P180031Intracranial coil-assist stentK242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter

View all 27 devices →

Related Devices (Code: HCG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262419MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MFCerenovus, Inc.K261772Target Xtra Detachable CoilStryker NeurovscularK260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.K254221Optima Coil System (OptiOne Coil System)Balt USA, LLCK252694Target Detachable CoilStryker NeurovascularK252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑